Efficacy of Placebo Versus Chlorpheniramine for the Prevention of Allergic Transfusion Reactions.
NCT ID: NCT04688736
Last Updated: 2025-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
6642 participants
INTERVENTIONAL
2021-01-01
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Placebo
Each recruited subject will oral 8mg placebo 20 minutes before blood transfusion.
Placebo
The tablet resembles chlorpheniramine but has no therapeutic value.
Chlorpheniramine
Each recruited subject will oral 8mg chlorpheniramine 20 minutes before blood transfusion.
Chlorpheniramine
An antihistamine that reduces the natural chemical histamine in the body.
Interventions
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Placebo
The tablet resembles chlorpheniramine but has no therapeutic value.
Chlorpheniramine
An antihistamine that reduces the natural chemical histamine in the body.
Eligibility Criteria
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Inclusion Criteria
* Subject is diagnosed with hematological disorder and requires blood product (i.e. suspended red blood cells, apheresis platelets, fresh frozen plasma) transfusions.
* Subject can fully understand and voluntarily sign informed consent forms.
Exclusion Criteria
* Subject experienced at least 1 moderate/severe or 2 mild allergic reactions in the past.
* Subject received glucocorticoid or allergy drugs within 24 hours before blood transfusion.
* Subject transfused with washed RBC.
* Received allo-HSCT transplantation before.
* Subject with heart failure.
* Subject suffered from sequelae of cardiovascular or cerebrovascular diseases.
* Pregnant or nursing women.
* Inability to understand or to follow study procedures.
18 Years
65 Years
ALL
No
Sponsors
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Institute of Hematology & Blood Diseases Hospital, China
OTHER
Responsible Party
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Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
Zhoukou Central Hospital
Zhoukou, Henan, China
The Second Affilated Hospital of Shandong First Medical University
Tai’an, Shandong, China
Regenerative Medicine Center
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IIT2020032
Identifier Type: -
Identifier Source: org_study_id
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